Dr Reddy's Laboratories Limited in a disclosure on Tuesday said it has received a Form 483 with 2 observations from the US Food and Drug Administration(US FDA) for its active pharmaceutical ingredients(API) plant at Srikakulam in Andhra Pradesh.
"The audit of our API manufacturing plant at Srikakulam, Andhra Pradesh by the US FDA, has been completed today. We have been issued a Form 483 with 2 observations, which we are addressing," the company said in a disclosure to Bombay Stock Exchange.
Srikakulam unit is among the three manufacturing facilities that had received a warning letter from the US FDA in November 2015. The completion of the audit of Srikakulam unit marks the conclusion of the re-inspection undertaken by the US drug regulator at all the three units following the corrective steps were taken by Dr Reddy's in response to the warning letter.
While all the three units had received the Form 483 with observations requiring further remediation related to the specific observations during the just concluded re-inspection process, Srikakulam unit received the least number of observations compared to 13 observations, including some repeat observations cited in the warning letter by its oncology formulations unit at Duvvada in Visakhapatnam of AP, and 3 observations by its Miryalaguda plant in Telangana.
